Bellicum Pharmaceuticals is a clinical stage pharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer, including both hematological and solid tumors, as well as orphan inherited blood disorders. We are dedicated to creating an exceptional work environment where we develop products that can make a difference in the quality of life for patients.

Bellicum has an outstanding opportunity for an Clinical Site Manager (CSM). This role can be remote, or out of our office in either San Francisco or Houston. The the Clinical Site Manager, reporting to the Associate Director, Clinical Site Management, is responsible for the management of day-to-day aspects of investigational site activities on assigned clinical trials. The CSM is responsible for implementing and executing clinical trials at the sites assigned under his/her responsibility. He/she should ensure compliance with international guidelines, local regulations and corporate policies and procedures.

Role Responsibilities

Successfully implements and executes phase I – III clinical trials at their assigned sites and builds positive working relationships with principal investigators and site personnel.

Ensure Monitoring and Data Review Plans are in place for assigned trials and that all monitoring activities are conducted according to study plans, relevant Bellicum processes and standard operations procedures (SOPs), GCP/ICH guidelines and other regulations.

Ensure all trial monitors receive appropriate protocol and therapeutic training. Maintain thorough knowledge of country regulations with special focus on regulatory requirements, guidance documents, and standards relating to global clinical trial conduct for biologics, and uses that knowledge to enhance site compliance and performance.

Experience in early phase trials (Phase I-II) and First-In-Man studies

Additional requirements include strong site and CRA management skills and communication skills. Ability to work both independently and as part of a team demonstrating excellent communication and interpersonal skills is required.

Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods.

Must be willing to travel to Houston occasionally.

We invite you to check us out www.bellicum.com. We offer a competitive Total Rewards program including stock options and employer paid benefit premiums. Interested candidates are invited to submit their resume to www.bellicum.com/about-us/careers. We thank you for your interest in Bellicum and your submission. Please be advised that only those candidates we will interview will be contacted.